Evaluation of the Concordance Between Measures Obtained by a Medical Device for Emotional Monitoring (EMOCARE) and the Patient Health Questionnaire (PHQ-9) Score in Patients With Mild to Severe Depressive Episode (EMC1)

Evaluation of the Concordance Between Measures Obtained by a Medical Device for Emotional Monitoring (EMOCARE) and the Patient Health Questionnaire (PHQ-9) Score in Patients With Mild to Severe Depressive Episode: Prospective, Multicentric, Comparative, Single Blind Clinical Investigation. EMC1 Study

The aim of this clinical investigation is to find out whether the EMOCARE emotional monitoring software provides consistent results compared with the tools available for assessing the emotional state of patients suffering from mild to moderately severe depressive episod. It will also provide information on how patients feel about the use of passive monitoring software (without the active involvement of patient). The main questions it aims to answer are as follows:

Does EMOCARE provide consistent results compared with tools already used in current practice? What are the medical problems encountered by participants when using EMOCARE?

The researchers will compare EMCOCARE to various questionnaires usually used in the management of patients suffering from depression (PHQ-9, MADRS, GAD-7, BDI-II, EQ-5D-5L).

Participants who agree to take part in the study, during a selection visit, will be able to:

1. Install the software on a digital interface (smartphone, computer, etc.) and activate or deactivate it whenever they wish during the 6-week follow-up period.
2. Attend 2 scheduled appointments at the centre (a first appointment then a second 6 weeks later) to complete a series of questionnaires, being questioned by the doctor, and fill in other questionnaires on their own.
3. At home, answer questionnaires independently, 2 weeks and 4 weeks after the first appointment.
4. Receive a telephone call from the doctor 3 weeks after the first appointment to find out how the participants are feeling.
5. Keep a diary with the symptoms they have experienced, any medical consultations they have made, or changes in drug treatment.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Device: EMOCARE software

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tanel PETELOT; Phone Number: +33 6 51 44 26 67; Email: tanel.petelot@emobot.fr

Study Locations

• France
  • Agen, France, 47000
    • Recruiting
    • Private psychiatric practice
  • Caen, France, 14000
    • Recruiting
    • Private psychiatric pratice
  • Laxou, France, 54521
    • Not yet recruiting
    • Centre Psychothérapique de Nancy
    • Principal Investigator: Raymund SCHWAN, Professor
  • Maxéville, France, 54320
    • Terminated
    • Private psychiatric practice
  • Nantes, France, 44093
    • Not yet recruiting
    • Centre Hospitalier Universitaire de Nantes
    • Principal Investigator: Anne SAUVAGET, Professor
  • Nantes, France, 44000
    • Recruiting
    • Private psychiatric practice
    • Principal Investigator: Claire GORZEGNO, Doctor
  • Paris, France, 75013
    • Not yet recruiting
    • Private psychiatric practice
  • Reims, France, 51000
    • Not yet recruiting
    • Private psychiatric practice
  • Rennes, France, 35000
    • Recruiting
    • Centre Hospitalier Guillaume Régnier
    • Principal Investigator: Jean-Marie BATAIL, Doctor
  • Saint-Grégoire, France, 35760
    • Recruiting
    • Private psychiatric practice
    • Principal Investigator: Mathilde DROUFFE, Doctor
  • Saint-Nazaire, France, 44600
    • Recruiting
    • Private psychiatric practice
    • Principal Investigator: Mériadec PIERRE-LE-SEAC'H, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient of both sexes aged 18 or over.
• Outpatient with unipolar depression (regardless of the time of the episode) (major depressive disorder).
• Patient with an episode of major depression supported by PHQ-9 score greater than or equal to 5.
• Patient with an episode of major depression supported by MADRS score greater than or equal to 7.
• Patient accustomed to regular use of a smartphone and/or computer
• Patient who, in the opinion of the investigator, will comply with the requirements of the protocol.
• Patient affiliated to a social security scheme or beneficiary of such a scheme.
• Patient who has received full information about how the clinical investigation shall be conducted and has signed an informed consent form.
• Patient who reads and understands French.
• Patient who has undergone clinical screening adapted to the clinical investigation.

Exclusion Criteria:

• Patient treated with antipsychotic drugs.
• Patient with an unstable pathology that could interfere with the study.
• Patient unable to communicate or cooperate with the investigator due to a low mental level, language difficulties or impaired cerebral function.
• Patient with an active suicidal tendency or patient who has had a suicidal episode in the last 6 months
• Patients with borderline personality disorders.
• Patient with a contra-indication to the product(s) under evaluation.
• Woman of childbearing age without effective contraception.
• Pregnant woman, birthing or breastfeeding mother
• Minor (not emancipated)
• Incapacitated person

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMOCARE	Device: EMOCARE software; Use of the EMOCARE software on the digital device of participant (smartphone, computer, etc.). The participant can activate and deactivate the software whenever he wishes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of scores EMOCARE	Absolute difference	From baseline to 6 weeks
Change of scores PHQ-9 self-administrered	Absolute difference	From baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Score EMOCARE	At baseline, at 2 weeks, at 4 weeks
Change of EMOCARE score	From baseline to 2 weeks, from baseline to 4 weeks
Score PHQ-9 self administered	At baseline, at 2 weeks, at 4 weeks, at 6 weeks
Change of score PHQ-9 self administered	From baseline to 2 weeks, From baseline to 4 weeks
Score PHQ-9 administered by an investigator	At baseline, at 6 weeks
Change of score PHQ-9 administered by an investigator	From baseline to 6 weeks
Score MADRS administered by an investigator	At baseline, at 6 weeks
Change of MADRS administered by an investigator	From baseline to 6 weeks
Score BDI-II	At baseline, at 6 weeks
Change of BDI-II	From baseline to 6 weeks
Score BDI-II	At baseline, at 2 weeks, at 4 weeks, at 6 weeks
Change of BDI-II	From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks
EMOCARE operating time	From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks
EQ-5D-5L	At baseline, at 6 weeks
Number of patient with adverse event	At baseline, at 2 weeks, at 3 weeks, at 4 weeks, at 6 weeks
Acceptability of medical device questionnaire	At baseline, at 6 weeks

Collaborators and Investigators

• Sponsor: Emobot
• Collaborators: Nantes University Hospital; Centre Hospitalier Guillaume Régnier, RENNES; Rumb; Private psychiatric practice, Saint-Nazaire; Groupement Hospitalier Paul Guiraud, Villejuif; Centre de Psychothérapie Nancéen, Laxou; Private psychiatric pratice, Agen; Private psychiatric pratice, Caen

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2025
• Primary Completion (Estimated): February 4, 2027
• Study Completion (Estimated): February 4, 2027

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 15, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: EB-EMC1-2024; 2024-A01487-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No